Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Exclusion Criteria

• •Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis
• •Imminently life-threatening EGPA at the time of screening.
• •History or presence of any form of cancer within 5 years prior to screening.
• •Serious liver, renal, blood, or psychiatric disease
• •Severe or clinically significant cardiovascular disease uncontrolled with standard treatment
• •Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections)
• •Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening.
• •HIV positive status
• •Active hepatitis due to hepatitis B virus or hepatitis C virus
• •Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus)
• •laboratory parameter exclusions:
• •1. Estimated glomerular filtration rate of \<30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations
• •2. WBC count \<4 × 109/L
• •3. Absolute lymphocyte count \<500 cells/mm3
• •4. Absolute neutrophil count \<1000 cells/mm3
• •5. Platelet count \<120,000/mm3
• •6. Hemoglobin \<8 g/dL (\<80 g/L)
• •Subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation
• •History of clinically significant drug or alcohol abuse within the last 6 months